Table 4

Most common treatment-emergent adverse events (occurring in ≥5% in any group; safety population)

28-day TIS56-day TISNon-randomised
Before month 3 (n=44)After month 3 (n=35)Before month 3 (n=43)After month 3 (n=36)Before month 3 (n=35)
Any adverse event32 (73)21 (60)25 (58)19 (53)7 (20)
Cough9 (20)9 (26)2 (5)7 (19)1 (3)
Rhinitis7 (16)3 (9)3 (7)2 (6)1 (3)
Dysphonia5 (11)06 (14)01 (3)
URTI4 (9)4 (11)2 (5)4 (11)0
Nasopharyngitis3 (7)002 (6)0
Headache3 (7)01 (2)00
Pyrexia3 (7)2 (6)4 (9)2 (6)0
Haemoptysis2 (5)1 (3)1 (2)00
Lung disorder2 (5)1 (3)02 (6)0
Oropharyngeal pain2 (5)2 (6)000
Bronchitis2 (5)3 (9)04 (11)0
Influenza2 (5)0000
Pseudomonas infection2 (5)1 (3)1 (2)1 (3)0
Drug level increased2 (5)01 (2)00
Tonsilitis1 (2)4 (11)01 (3)0
Productive cough1 (2)02 (5)1 (3)0
Vomiting1 (2)01 (2)3 (8)0
Otitis media03 (9)1 (2)2 (6)0
Sinusitis02 (6)000
Deafness002 (5)00
Varicella001 (2)3 (8)0
  • Values shown are n (%).

  • No adverse events were reported in the non-randomised group after month 3.

  • TIS, tobramycin inhalation solution 300 mg/5 ml ; URTI, upper respiratory tract infection.